CA2509976C - Modified release pharmaceutical composition - Google Patents
Modified release pharmaceutical composition Download PDFInfo
- Publication number
- CA2509976C CA2509976C CA2509976A CA2509976A CA2509976C CA 2509976 C CA2509976 C CA 2509976C CA 2509976 A CA2509976 A CA 2509976A CA 2509976 A CA2509976 A CA 2509976A CA 2509976 C CA2509976 C CA 2509976C
- Authority
- CA
- Canada
- Prior art keywords
- pharmaceutical composition
- composition according
- capsule
- coating
- coated
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
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- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 56
- 239000002775 capsule Substances 0.000 claims abstract description 188
- 239000013543 active substance Substances 0.000 claims abstract description 73
- 239000008187 granular material Substances 0.000 claims abstract description 62
- 238000000576 coating method Methods 0.000 claims description 79
- 239000011248 coating agent Substances 0.000 claims description 69
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 52
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 52
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 52
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 52
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims description 24
- 239000000203 mixture Substances 0.000 claims description 22
- -1 glidants Substances 0.000 claims description 21
- 229920000642 polymer Polymers 0.000 claims description 17
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- 239000000126 substance Substances 0.000 claims description 14
- 238000010521 absorption reaction Methods 0.000 claims description 13
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- 239000000546 pharmaceutical excipient Substances 0.000 claims description 10
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- 210000001035 gastrointestinal tract Anatomy 0.000 claims description 8
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- 239000011230 binding agent Substances 0.000 claims description 6
- 239000003814 drug Substances 0.000 claims description 6
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 claims description 4
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 claims description 4
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- 239000003242 anti bacterial agent Substances 0.000 claims description 2
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- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 28
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- 238000002360 preparation method Methods 0.000 description 12
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- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 description 8
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- 239000000243 solution Substances 0.000 description 7
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 description 6
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 6
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 description 6
- 229920002907 Guar gum Polymers 0.000 description 6
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 6
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 6
- 239000005913 Maltodextrin Substances 0.000 description 6
- 229920002774 Maltodextrin Polymers 0.000 description 6
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 6
- 229920000881 Modified starch Polymers 0.000 description 6
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 6
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 6
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 6
- 235000010443 alginic acid Nutrition 0.000 description 6
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- 150000004781 alginic acids Chemical class 0.000 description 6
- PZZYQPZGQPZBDN-UHFFFAOYSA-N aluminium silicate Chemical compound O=[Al]O[Si](=O)O[Al]=O PZZYQPZGQPZBDN-UHFFFAOYSA-N 0.000 description 6
- 229910000323 aluminium silicate Inorganic materials 0.000 description 6
- 229910052791 calcium Inorganic materials 0.000 description 6
- 239000001768 carboxy methyl cellulose Substances 0.000 description 6
- 239000001913 cellulose Substances 0.000 description 6
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- BXWNKGSJHAJOGX-UHFFFAOYSA-N hexadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCO BXWNKGSJHAJOGX-UHFFFAOYSA-N 0.000 description 6
- IPCSVZSSVZVIGE-UHFFFAOYSA-N hexadecanoic acid Chemical compound CCCCCCCCCCCCCCCC(O)=O IPCSVZSSVZVIGE-UHFFFAOYSA-N 0.000 description 6
- 229910052749 magnesium Inorganic materials 0.000 description 6
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- 235000019814 powdered cellulose Nutrition 0.000 description 6
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- 235000010413 sodium alginate Nutrition 0.000 description 6
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- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 description 4
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4891—Coated capsules; Multilayered drug free capsule shells
Landscapes
- Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SI200200318A SI21349A (sl) | 2002-12-24 | 2002-12-24 | Plavajoča farmacevtska oblika s prirejenim sproščanjem zdravilne učinkovine |
| SIP-200200318 | 2002-12-24 | ||
| SIP-200300246 | 2003-09-24 | ||
| SI200300246A SI21602A (sl) | 2003-09-24 | 2003-09-24 | Plavajoča farmacevtska oblika s prirejenim sproščanjem zdravilne učinkovine |
| PCT/SI2003/000048 WO2004058230A1 (en) | 2002-12-24 | 2003-12-23 | Modified release pharmaceutical composition |
Publications (2)
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| CA2509976A1 CA2509976A1 (en) | 2004-07-15 |
| CA2509976C true CA2509976C (en) | 2012-03-13 |
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| CA2509976A Expired - Fee Related CA2509976C (en) | 2002-12-24 | 2003-12-23 | Modified release pharmaceutical composition |
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|---|---|
| US (1) | US7485322B2 (es) |
| EP (1) | EP1578406B1 (es) |
| AT (1) | ATE396712T1 (es) |
| AU (1) | AU2003286994A1 (es) |
| BR (1) | BRPI0317682B1 (es) |
| CA (1) | CA2509976C (es) |
| DE (1) | DE60321386D1 (es) |
| DK (1) | DK1578406T3 (es) |
| EA (1) | EA011373B1 (es) |
| ES (1) | ES2305537T3 (es) |
| MX (1) | MXPA05006916A (es) |
| PL (1) | PL207776B1 (es) |
| PT (1) | PT1578406E (es) |
| SI (1) | SI1578406T1 (es) |
| WO (1) | WO2004058230A1 (es) |
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| US6607751B1 (en) * | 1997-10-10 | 2003-08-19 | Intellipharamaceutics Corp. | Controlled release delivery device for pharmaceutical agents incorporating microbial polysaccharide gum |
| WO2004112756A1 (en) | 2003-06-26 | 2004-12-29 | Isa Odidi | Proton pump-inhibitor-containing capsules which comprise subunits differently structured for a delayed release of the active ingredient |
| US8394409B2 (en) | 2004-07-01 | 2013-03-12 | Intellipharmaceutics Corp. | Controlled extended drug release technology |
| US10624858B2 (en) * | 2004-08-23 | 2020-04-21 | Intellipharmaceutics Corp | Controlled release composition using transition coating, and method of preparing same |
| US9463426B2 (en) * | 2005-06-24 | 2016-10-11 | Boston Scientific Scimed, Inc. | Methods and systems for coating particles |
| US10064828B1 (en) | 2005-12-23 | 2018-09-04 | Intellipharmaceutics Corp. | Pulsed extended-pulsed and extended-pulsed pulsed drug delivery systems |
| CN101453996B (zh) * | 2006-04-03 | 2016-05-11 | 伊萨·奥迪迪 | 药物递送组合物 |
| CN104825397A (zh) * | 2006-04-03 | 2015-08-12 | 伊萨·奥迪迪 | 含有机溶胶涂层的受控释放递送物件 |
| US10960077B2 (en) | 2006-05-12 | 2021-03-30 | Intellipharmaceutics Corp. | Abuse and alcohol resistant drug composition |
| PL216542B1 (pl) * | 2008-03-20 | 2014-04-30 | Zakłady Farmaceutyczne POLPHARMA Spółka Akcyjna | Sposób wytwarzania stabilnej kompozycji orlistatu w postaci kapsułkowanego proszku |
| AR077712A1 (es) | 2009-08-05 | 2011-09-14 | Idenix Pharmaceuticals Inc | Inhibidores de serina proteasa macrociclica |
| WO2011056764A1 (en) | 2009-11-05 | 2011-05-12 | Ambit Biosciences Corp. | Isotopically enriched or fluorinated imidazo[2,1-b][1,3]benzothiazoles |
| MY159958A (en) | 2009-12-18 | 2017-02-15 | Idenix Pharmaceuticals Inc | 5,5-fused arylene or heteroarylene hepatitis c virus inhibitors |
| WO2011094890A1 (en) | 2010-02-02 | 2011-08-11 | Argusina Inc. | Phenylalanine derivatives and their use as non-peptide glp-1 receptor modulators |
| WO2011112689A2 (en) | 2010-03-11 | 2011-09-15 | Ambit Biosciences Corp. | Saltz of an indazolylpyrrolotriazine |
| US8703943B2 (en) | 2010-09-01 | 2014-04-22 | Ambit Biosciences Corporation | Optically active pyrazolylaminoquinazoline, and pharmaceutical compositions and methods of use thereof |
| MX2013002383A (es) | 2010-09-01 | 2013-07-05 | Ambit Biosciences Corp | Sales bromhidrato de una pirazolilaminoquinazolina. |
| JP2014500275A (ja) | 2010-12-06 | 2014-01-09 | フォリカ，インコーポレイテッド | 禿頭症を治療するため、および毛髪の成長を促進するための方法 |
| WO2012080050A1 (en) | 2010-12-14 | 2012-06-21 | F. Hoffmann-La Roche Ag | Solid forms of a phenoxybenzenesulfonyl compound |
| JP2014503597A (ja) | 2011-01-31 | 2014-02-13 | セルジーン コーポレイション | シチジンアナログの医薬組成物及びその使用方法 |
| TW201309690A (zh) | 2011-02-10 | 2013-03-01 | Idenix Pharmaceuticals Inc | 巨環絲胺酸蛋白酶抑制劑，其醫藥組合物及其於治療ｈｃｖ感染之用途 |
| US20120252721A1 (en) | 2011-03-31 | 2012-10-04 | Idenix Pharmaceuticals, Inc. | Methods for treating drug-resistant hepatitis c virus infection with a 5,5-fused arylene or heteroarylene hepatitis c virus inhibitor |
| US10137094B2 (en) | 2011-10-11 | 2018-11-27 | Sun Pharmaceutical Industries Limited | Gastroretentive dosage system and process of preparation thereof |
| CN104302640A (zh) | 2012-03-16 | 2015-01-21 | 埃克希金医药品有限公司 | 3,5-二氨基吡唑激酶抑制剂 |
| NZ631142A (en) | 2013-09-18 | 2016-03-31 | Axikin Pharmaceuticals Inc | Pharmaceutically acceptable salts of 3,5-diaminopyrazole kinase inhibitors |
| EP3046924A1 (en) | 2013-09-20 | 2016-07-27 | IDENIX Pharmaceuticals, Inc. | Hepatitis c virus inhibitors |
| WO2015134560A1 (en) | 2014-03-05 | 2015-09-11 | Idenix Pharmaceuticals, Inc. | Solid forms of a flaviviridae virus inhibitor compound and salts thereof |
| CA2943231C (en) | 2014-03-20 | 2023-10-24 | Capella Therapeutics, Inc. | Benzimidazole derivatives as erbb tyrosine kinase inhibitors for the treatment of cancer |
| IL291000B2 (en) | 2014-03-20 | 2024-04-01 | Capella Therapeutics Inc | Benzimidazole derivatives as erbb tyrosine kinase inhibitors for the treatment of cancer |
| MY191736A (en) | 2014-12-23 | 2022-07-13 | Axikin Pharmaceuticals Inc | 3,5-diaminopyrazole kinase inhibitors |
| CN107007838B (zh) * | 2016-09-30 | 2021-07-20 | 南京优科制药有限公司 | 一种含有马来酸依那普利、叶酸和酸稳定剂的药物组合物 |
| CN113768898A (zh) * | 2021-09-14 | 2021-12-10 | 江苏万邦生化医药集团有限责任公司 | 悬浮的胶囊片 |
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| US1815902A (en) * | 1927-07-16 | 1931-07-28 | Nat Aniline & Chem Co Inc | Device for administering medicaments |
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| WO1998050019A1 (en) | 1997-05-09 | 1998-11-12 | Sage Pharmaceuticals, Inc. | Stable oral pharmaceutical dosage forms |
| WO2000018377A1 (en) * | 1998-09-28 | 2000-04-06 | Warner-Lambert Company | Enteric and colonic delivery using hpmc capsules |
| IL147826A0 (en) * | 1999-07-30 | 2002-08-14 | Smithkline Beecham Plc | Multi-component pharmaceutical dosage form |
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| US20030194430A1 (en) * | 2002-04-10 | 2003-10-16 | Miller Frederick H. | Process for encapsulating multi-phase, multi-compartment capsules for therapeutic compositions |
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2003
- 2003-12-18 US US10/740,208 patent/US7485322B2/en not_active Expired - Fee Related
- 2003-12-23 EP EP03777508A patent/EP1578406B1/en not_active Expired - Lifetime
- 2003-12-23 MX MXPA05006916A patent/MXPA05006916A/es active IP Right Grant
- 2003-12-23 EA EA200500909A patent/EA011373B1/ru not_active IP Right Cessation
- 2003-12-23 AU AU2003286994A patent/AU2003286994A1/en not_active Abandoned
- 2003-12-23 WO PCT/SI2003/000048 patent/WO2004058230A1/en not_active Ceased
- 2003-12-23 DE DE60321386T patent/DE60321386D1/de not_active Expired - Lifetime
- 2003-12-23 SI SI200331331T patent/SI1578406T1/sl unknown
- 2003-12-23 BR BRPI0317682-7A patent/BRPI0317682B1/pt not_active IP Right Cessation
- 2003-12-23 ES ES03777508T patent/ES2305537T3/es not_active Expired - Lifetime
- 2003-12-23 CA CA2509976A patent/CA2509976C/en not_active Expired - Fee Related
- 2003-12-23 AT AT03777508T patent/ATE396712T1/de active
- 2003-12-23 DK DK03777508T patent/DK1578406T3/da active
- 2003-12-23 PL PL376099A patent/PL207776B1/pl unknown
- 2003-12-23 PT PT03777508T patent/PT1578406E/pt unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP1578406B1 (en) | 2008-05-28 |
| WO2004058230A1 (en) | 2004-07-15 |
| EA200500909A1 (ru) | 2006-02-24 |
| EP1578406A1 (en) | 2005-09-28 |
| PT1578406E (pt) | 2008-09-01 |
| MXPA05006916A (es) | 2005-08-18 |
| PL207776B1 (pl) | 2011-01-31 |
| DE60321386D1 (de) | 2008-07-10 |
| BR0317682A (pt) | 2005-11-29 |
| ES2305537T3 (es) | 2008-11-01 |
| SI1578406T1 (sl) | 2009-02-28 |
| DK1578406T3 (da) | 2008-09-08 |
| US7485322B2 (en) | 2009-02-03 |
| AU2003286994A1 (en) | 2004-07-22 |
| PL376099A1 (en) | 2005-12-12 |
| ATE396712T1 (de) | 2008-06-15 |
| US20040131669A1 (en) | 2004-07-08 |
| BRPI0317682B1 (pt) | 2015-04-14 |
| EA011373B1 (ru) | 2009-02-27 |
| CA2509976A1 (en) | 2004-07-15 |
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| EEER | Examination request | ||
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Effective date: 20171227 |